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510(k) Data Aggregation

    K Number
    K960810
    Device Name
    BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM
    Date Cleared
    1996-10-21

    (236 days)

    Product Code
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARLO SURGICAL TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation.
    Device Description
    The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation.
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    K Number
    K962273
    Device Name
    MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST
    Date Cleared
    1996-07-31

    (48 days)

    Product Code
    Regulation Number
    884.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARLO SURGICAL TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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